ever, two-thirds of those products
were launched between 2011
and 2015. It also appears that the
potential of first-time launches to
generate high revenue is improving; between 2011 and 2015, seven
products (Imbruvica®, Incivek®,
Kerydin®, Kyprolis®, Linzess®,
Lonsurf®, and Tivicay®) achieved
over $100 million in first year
sales, whereas only one product
(Ampyra®) had done so between

2006 and 2010.2 (See Figure 1)

THE LAUNCH CHALLENGE

Whether for a small or large
company, launching a drug successfully is a colossal undertaking.

According to PhRMA, on average
it takes about 10 years and up to

$2.6 billion to bring a product tomarket. And the risk of failure isinfamously high; the probabilitythat a drug entering clinical stud-ies will actually make it to marketis less than 12 percent.
3 The costsand risks of late-phase develop-ment and commercialization aretied to several industry trends:• The legal and regulatory hur-dles to approval are constantlychanging—in particular, regula-tors tend to be requiring moreextensive clinical trials, oftenwith commitments for post-mar-keting surveillance.

• The marketplace is ever morecompetitive and the expectationsof stakeholders such as regula-tors, payers, providers, patientsand patient advocacy groups areever higher. There is an increas-ing trend towards patient-fo-cused drug development whichrequires a better understandingof how a disease impacts thequality of life (QOL) and sur-vival of a patient. Stakeholdersare requiring more real-worldevidence on how new drugs andtechnologies impact patients’QOL and survival rates in thereal world settings and not onlydata from clinical trials.

• Regulators need this data
to understand safety of a new
product when it becomes
widely available, typically
through post marketing surveillance.

• Payers need this data to determine the clinical value of a
new product, its cost effectiveness and ultimately its optimal
formulary placement.

Incivek generated 1.4B in first year sales. Not shown on the chart because of scale